High-fiber Diet on the Body and the Brain

NCT ID: NCT03829189

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-14

Study Completion Date

2020-11-24

Brief Summary

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The central research question aims to understand what drives individuals to make and maintain a vegan / vegetarian dietary decision, to investigate whether there are possible predictors that might influence such a decision and whether personality differences already exist or can only be measured after the change in diet. The investigators will examine the effects of a high-fiber diet on food wanting on a neural and on a behavioral level. The microbiome is suggested to mediate the expected changes in food wanting.

Detailed Description

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Conditions

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Diet Modification Overweight

Keywords

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microbiome food wanting memory fiber

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Arm 1: inulin; minimum of 14 days wash-out; 14 days placebo Arm 2: 14 days placebo; minimum of 14 days wash-out; 14 days placebo
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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inulin

Group Type ACTIVE_COMPARATOR

inulin

Intervention Type DIETARY_SUPPLEMENT

prebiotic supplement

maltodextrin

Group Type PLACEBO_COMPARATOR

maltodextrin

Intervention Type DIETARY_SUPPLEMENT

placebo supplement

Interventions

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inulin

prebiotic supplement

Intervention Type DIETARY_SUPPLEMENT

maltodextrin

placebo supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* body-mass-index 25-30kg/m\^2
* females on contraception only

Exclusion Criteria

* current neurological or psychiatric illness
* daily consumption of more than 50 g of alcohol, more than 10 cigarettes or more than 6 cups of coffee
* use of antidepressants or other centrally acting drugs
* type 2 diabetes mellitus or other serious metabolic disorders
* MRI contraindication (e.g. cardiac pacemaker, drug pump, shunts)
* major untreated medical condition, including gastrointestinal organs, lungs, heart, cardiovascular system, liver and kidney)
* diet-related restrictions (food allergies, food intolerances, known nutrient deficiencies or a recent history of dieting or restrictive eating behaviour, including vegan, vegetarian diet)
* current pregnancy or lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Max Planck Institute for Human Cognitive and Brain Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

References

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Medawar E, Beyer F, Thieleking R, Haange SB, Rolle-Kampczyk U, Reinicke M, Chakaroun R, von Bergen M, Stumvoll M, Villringer A, Witte AV. Prebiotic diet changes neural correlates of food decision-making in overweight adults: a randomised controlled within-subject cross-over trial. Gut. 2024 Jan 5;73(2):298-310. doi: 10.1136/gutjnl-2023-330365.

Reference Type DERIVED
PMID: 37793780 (View on PubMed)

Medawar E, Haange SB, Rolle-Kampczyk U, Engelmann B, Dietrich A, Thieleking R, Wiegank C, Fries C, Horstmann A, Villringer A, von Bergen M, Fenske W, Veronica Witte A. Gut microbiota link dietary fiber intake and short-chain fatty acid metabolism with eating behavior. Transl Psychiatry. 2021 Oct 1;11(1):500. doi: 10.1038/s41398-021-01620-3.

Reference Type DERIVED
PMID: 34599144 (View on PubMed)

Other Identifiers

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GUT_BRAIN

Identifier Type: -

Identifier Source: org_study_id